Innovative Physiotherapy in Stroke Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2021-12-05

Brief Summary

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The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL.

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Detailed Description

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The purpose of the RCT is to investigate the effects of an innovative physiotherapy intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge from a stroke unit and throughout the rehabilitation chain.The project investigate: 1) effects on postural control and balance in various positions and functional activities. Effects on and level of physical activity, and 2) user's identifications of positive and negative features in content and coordination of physiotherapy integrated in post stroke rehabilitation. Function parameters of balance, gait and levels of physical activity at baseline and at 12 weeks will be compared to those obtained from the standard care group. Semistructured interviews will be conducted to identify patients' perceptions of key positive and negative features of content and coordination of I-CoreDIST and standard care rehabilitation after a stroke.

Conditions

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Stroke, Ischemic Stroke Hemorrhagic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel trial. After baseline assessment, the participants will be randomly assigned to one of two trial arms, A and B, in a 1:1 ratio.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ICoreDIST

The intervention starts with an assessment by the physiotherapist to identify the patient's movement problems in order to choose among the 48 exercises in the intervention. Each session lasts for 60 minutes + exercises 5-10 minutes outside of therapy and is performed 5-6 days/per week in the rehabilitation units, and 3 sessions/week + home exercises 30 minutes 3 days per week in home based or outpatient treatment during the 12 weeks period.To allow for individualisation, each exercise contains five levels of difficulty. All exercises demand enhancement of dynamic trunk stability and functional movements.

Group Type EXPERIMENTAL

ICoreDIST

Intervention Type PROCEDURE

The intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following:

1. Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts.
2. Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration.
3. Proximal stability prior to selective task-oriented movement of limbs, head, eyes.
4. Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs.
5. Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment.
6. Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking.

Standard Care

Consists of standard inpatient rehabilitation, home-based and outpatient-based physiotherapy with the same dose as the intervention group.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type PROCEDURE

According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.

Interventions

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ICoreDIST

The intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following:

1. Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts.
2. Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration.
3. Proximal stability prior to selective task-oriented movement of limbs, head, eyes.
4. Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs.
5. Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment.
6. Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking.

Intervention Type PROCEDURE

Standard Care

According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* A stroke diagnosis
* Can sit for 10 seconds without support
* Age 18-85
* Trunk Impairment Scale-Norwegian version (TIS-NV) \< 15
* Pre-stroke modified Ranking Scale (mRS) 0-3

Exclusion Criteria

* Dementia
* Unable to cooperate in physiotherapy
* On-going substance abuse
* Severe co-morbidity preventing rehabilitation, severe neurological diseases such as Parkinson disease, Multiple Sclerosis and brain tumor.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No